Combining acetaminophen and ibuprofen to treat heart issues in premature infants
Official title: Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants - The ACEDUCT Trial
Run by Mount Sinai Hospital, Canada · NCT05340582 · Data updated 2026-11-12
This study is testing if giving premature infants both acetaminophen and ibuprofen together can help treat a heart problem called patent ductus arteriosus better than using just one of the medicines alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 27 Weeks |
| Sex | All |
| Enrollment | 310 (estimated) |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 9 sites (Newcastle, New South Wales and 8 other locations) |
| Status | Recruiting |
| Started | December 12, 2022 |
| Main results expected | January 2027 |
| Study ends | April 2027 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT05340582 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are preterm infants born at less than 27 weeks gestation who have been diagnosed with PDA.
✕Probably not a fit
Patients with chromosomal anomalies or pre-existing renal or hepatic dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of co-administering acetaminophen and ibuprofen to treat patent ductus arteriosus (PDA) in extremely premature infants born at less than 27 weeks gestation. PDA is a common cardiovascular complication in these infants, often leading to increased mortality and morbidity. The study aims to determine if this combination therapy can reduce treatment failure rates compared to using either medication alone. The trial will involve preterm infants diagnosed with PDA and will assess outcomes through echocardiography and clinical evaluations.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for extremely premature infants suffering from PDA.
How similar studies have gone: While combination therapies are emerging, this specific approach has not been widely tested, making it a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants born \<27+0 weeks gestational age * Permission given by the attending clinician to approach and then consent obtained from parents * Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt * Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team. Exclusion Criteria: * Chromosomal anomaly * Pre-treatment renal dysfunction defined as urine output \< 1ml/kg/hour for the previous 24 hours or serum creatinine \> 100 micromol/L * Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) \> 100 units/L94 * Platelet count \<50,000 per microliter * Permission denied by the attending clinician to approach parents * Parental consent not available * Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).
Where it's running
-
Royal North Shore Hospital
St Leonards, New South Wales, Australia Recruiting -
Royal Alexandra Hospital
Edmonton, Ontario, Canada Recruiting -
McMaster Children's Hospital
Hamilton, Ontario, Canada Recruiting -
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting -
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting -
Centre Hospitalier de l'Université Laval
Québec, Quebec, Canada Recruiting
Show 3 more locations
-
John Hunter Hospital
Newcastle, New South Wales, Australia Active not recruiting -
Prince of Wales Hospital
Shatin, Nt, Hong Kong Not yet recruiting -
The Rotunda Hospital
Dublin, Ireland Active not recruiting
Study contacts
- Principal investigator: Amish Jain, MD PhD — Mount Sinai Hospital
- Study coordinator: Laura Thomas, MSc
- Email: laura.thomas@sinaihealth.ca
- Phone: 416-586-4800
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.